This phase 2 clinical trial will test the effectiveness of TGR-1202 in patients with relapsed or refractory follicular lymphoma. The primary outcome will be measured by the overall response rate. This trial is being conducted at the Columbia University Medical Center in New York, New York.
The details
TGR-1202 (umbralisib) is an inhibitor of phosphoinositide 3-kinase (PI3K) delta, a protein that helps carry out signals for growth and division in early B-cells. Blocking this protein will stop the growth of cancerous B-cells, eventually leading to cell death. Early clinical trials testing PI3K inhibitors have demonstrated promising results for treating lymphoma.
The study will examine the overall response, time to disease progression, and number of adverse (negative) side effects for up to 3 years. The trial will also assess the number of dose delays (patient delays delivery of dose) and dose reductions (due to side effects).
Who are they looking for?
This trial is recruiting 20 patients with stage 1-3a follicular lymphoma who have relapsed after prior immunotherapy or immunochemotherapy. Participants must have adequate organ and bone marrow function. Patients should not have prior exposure to PI3K inhibitors or exposure to other systemic anticancer treatments within 3 weeks of entry.
Participants should not have received a stem cell transplant prior to the study. Patients should not have any active infections. Patients cannot have significant cardiovascular abnormalities, gastrointestinal (GI) surgery that may affect absorption, or any uncontrolled medical condition. Patients with a history of prior malignancy must be disease free for at least 3 years. Male and female participants must agree to use contraception for up to 1 month following treatment.
How will it work
Patients will take one tablet of TGR-1202 daily by mouth throughout a 28-day cycle. Patients will be treated and followed for up to 3 years.
